PATIENT INFORMATION LEAFLET

PantoprazolVir Pharma 40 mg gastro-resistant tablets EFG

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

• If you consider that any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

1.What is PantoprazolVir Pharmaand what it is used for

2.Before taking PantoprazolVir Pharma

3.How to take PantoprazolVir Pharma

4.Possible side effects

5.Storage of PantoprazolVir Pharma

6.Additional information

PantoprazolVir Pharmais a selective proton pump inhibitor, a medication that reduces the amount of acid produced in your stomach. It is used for the treatment ofconditions related to stomach and intestinal acid.

PantoprazolVir Pharmais used for:

Adults and adolescents 12 years and older:

• Gastroesophageal reflux esophagitis. It is aninflammation of your esophagus (the tube thatconnects your throat with your stomach) accompanied by regurgitation of acid from your stomach.

Adults:

• Infectionofa bacterium calledHelicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment). The goal is to get rid of the bacterium and thus reduce the likelihood of ulcers reappearing.
• -Stomachulcersand duodenal ulcers, and
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in thestomach.

Do not take Pantoprazol Vir Pharma

• If you are allergic (hypersensitive) to pantoprazole or to any of the other components of Pantoprazol Vir Pharma (see section 6).

• If you are allergic to medications that contain other proton pump inhibitors (e.g. omeprazole, lansoprazole, rabeprazole, esomeprazole)

Be especially careful with Pantoprazol Vir Pharma

• If you have severe liver problems. Inform your doctor if you have ever had liver problems. Your doctor will monitor your liver enzymes more frequently, especially when you are on long-term treatment with pantoprazole. If liver enzyme levels increase, treatment should be interrupted.

• If you have reduced vitamin B12 reserves or risk factors for it and receive pantoprazole treatment for a long period of time. Like all medications that reduce acid production, pantoprazole may reduce vitamin B12 absorption.

• Consult your doctor if you are taking any medication that contains atazanavir (for HIV treatment) at the same time as pantoprazole.

Inform your doctor immediately if you notice any of the following symptoms:

• Unintentional weight loss
• Recurring vomiting
• Difficulty swallowing
• Blood in the vomit
• Pale appearance and feeling of weakness (anemia)
• Blood in your stools
• Severe or persistent diarrhea, as pantoprazole has been associated with a small increase in infectious diarrhea.

Your doctor will decide if you need additional testing to rule out a malignant disease, as pantoprazole may alleviate cancer symptoms and potentially delay diagnosis. If your symptoms persist despite treatment, further investigations will be performed.

If you take pantoprazole for a prolonged period (over one year), your doctor may regularly monitor you. You should inform your doctor of any new or unexpected symptoms and/or events each time you attend your consultation.

Use of other medications

Pantoprazol Vir Pharma may affect the efficacy of other medications, so inform your doctor if you are taking

• Medications such as ketoconazole, itraconazole, and posaconazole (used for fungal infections) or erlotinib (used for certain types of cancer), as Pantoprazol Vir Pharma may make these and other medications not work correctly.
• Warfarin and fenprocoumon, which affect blood coagulation. You may need additional monitoring.
• Atazanavir (used for HIV treatment).

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Pregnancy and breastfeeding

There is insufficient data on the use of pantoprazole in pregnant women. It has been noted that in humans, pantoprazole is excreted in breast milk. If you are pregnant, or think you may be pregnant, or if you are breastfeeding, you should only use this medication if your doctor considers the benefits for you to be greater than the potential risk to the fetus or baby.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

You should not drive or operate machinery if you experience adverse effects such as dizziness or blurred vision.

Follow exactly the administration instructions for PantoprazolVir Pharmaas indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

When and how should you take PantoprazolVir Pharma?

Take the whole tablets, without chewing or crushing, with a little water, 1 hour beforea meal.

Unless your doctor has indicated otherwise, the normal dose is:

Adults and adolescents 12 years and older:

For the treatment of esophagitisdue to reflux:

The usual dose isonetablet per day. Yourdoctor may indicate an increase totwo tablets per day.

The treatment durationforesophagitisdue toreflux is usually between 4 and 8 weeks.Your doctor will indicate for how long you should take this medication.

Adults:

For the treatment of an infection with abacteria calledHelicobacter pyloriin patients with stomach and/or duodenal ulcers in combination with two antibiotics (eradication treatment)

Onetablettwice a day plus thetwoantibiotic tablets, eitheramoxicillin, clarithromycin, and metronidazole(or tinidazole),eachshould be takentwice a day with your pantoprazole tablet. Take the first pantoprazole tablet1hour before breakfast and the second1 hourbefore dinner. Follow your doctor's instructions and make sure to read the antibiotic prospectuses.

The treatment duration is usually betweenone and twoweeks.

For the treatmentofstomach and duodenal ulcers:

The usual dose isonetablet per day.

The dose may bedoubledby your doctor.

Your doctor will indicate for how long you should take this medication. The treatment duration forstomach ulcers is usually between 4 and 8 weeks.The treatment duration forduodenal ulcersis usually between 2 and 4 weeks.

For long-term treatment of the Zollinger-Ellison Syndrome and otherconditions in which there is an increase in stomach acid production:

The initial recommended dose istwotablets per day. Take thetwotablets1 hourbefore a meal.

Your doctor may adjust your dose, depending on the amount of stomach acid you produce.If you are prescribed more than two tablets per day, you should take the tablets divided into two doses per day.

Ifyou are prescribed more thanfourtablets per day, you will be told exactly when to stop treatment.

Special patient groups:

• If you have kidney problems,or moderate or severeliver problems,you should not take pantoprazol fortheHelicobacter pylorielimination.

• If you have severe liver problems, you should not take more thanone20 mg pantoprazol tabletper day(for this case, 20 mg pantoprazol tablets are available).
• Children(under 12 years):the use of these tablets is not recommended in children under 12years.

If you take morePantoprazolVir Pharma than you should

Inform your doctor or pharmacist or call the Toxicological Information Service phone91 562 04 20,indicating the medication and the amountingested. There are no known symptoms of overdose.

If you forget to takePantoprazolVir Pharma

Do not take a double dose to compensate for the missed doses.Take yournextdose as usual.

If you interrupt the treatment with PantoprazolVir Pharma

Do not stop taking these tablets without consulting your doctor or pharmacist first.

If you have any other doubts about the use of thisproduct,ask your doctor or pharmacist.

Like all medications, PantoprazolVir Pharmamayproduceside effects, although not everyone will experience them.

The frequency of the possible side effects described below, is classified as follows:

veryfrequent(affects more than one patient in every 10)

common (affects between 1 and 10 patients in every 100)

infrequent(affects between 1 and 10 patients in every 1,000)

uncommon (affects between 1 and 10 patients in every 10,000)

veryuncommon(affects fewer than 1 patient in every 10,000)

frequency unknown (cannot be estimated from the available data).

If you experience any of the following side effects, stop taking these tablets and inform your doctor immediately, or contact the hospital's emergency service nearest to you:

• Severe allergic reactions (rare frequency): swelling ofthe tongue and/orthroat, difficultyswallowing, hives (urticaria), difficultybreathing, swellingof the face of allergic origin(Quincke's edema/angioedema), intense dizzinesswith very rapid heartbeats and excessive sweating.

• Severe skin alterations (unknown frequency):blistering of the skin and a rapid deterioration of the general condition, erosion (including slight bleeding) of the eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme) and sensitivity to light.
• Other serious conditions (unknown frequency):yellowing of the skin and the white of the eyes (severe liver cell damage, jaundice), or fever, hives, increased size of the kidneys with occasional pain when urinating and lower back pain (severe kidney inflammation)

Other side effectsare:

• Infrequent(affects between 1 and 10 patients in every 1,000)

headache; dizziness; diarrhea; sensation of dizziness, vomiting; swelling and flatulence (gas); constipation; dry mouth; abdominal pain and discomfort; hives on the skin, exanthema, rash; tingling; feeling of weakness, fatigue or general malaise; sleep disturbances.

• Uncommon(affects between 1 and 10 patients in every 10,000)

vision disturbances such as blurred vision; hives; joint pain; muscle pain; weight changes; increased body temperature; swelling in the extremities (peripheral edema); allergic reactions; depression; breast enlargement in men.

• Very uncommon(affects fewer than 1 patient in every 10,000)disorientation
• Unknown frequency(cannot be estimated from the available data)

hallucination, confusion (especially in patients with a history of these symptoms), decreased sodium levels in the blood, inflammation of the large intestine causing persistent watery diarrhea.

Side effects identified through blood tests:

• Infrequent(affects between 1 and 10 patients in every 1,000)

increase in liver enzymes

• Uncommon(affects between 1 and 10 patients in every 10,000)

increase in bilirubin; increase in blood fats

• Very uncommon(affects fewer than 1 patient in every 10,000)

reduction in platelet count which could cause bleeding or more frequent bruising; reduction in white blood cell count which could lead to more frequent infections.

Unknown frequency:

If you are taking PantoprazolVir Pharmafor more than three months, it is possible that magnesium levels in the blood may decrease. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate. If you experience any of these symptoms, see your doctor immediately. Low magnesium levels can also produce a decrease in potassium and calcium levels in the blood. Your doctor may decide to perform periodic blood tests to monitor magnesium levels.

If you are taking proton pump inhibitors such as PantoprazolVir Pharma, especially for a period of more than one year, it may slightly increase the risk of hip, wrist, and spinal fractures. Inform your doctor if you have osteoporosis or if you are taking corticosteroids (they may increase the risk of osteoporosis).

If you consider that any of the side effects you are experiencing is severeor if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep this medication out of the sight and reach of children.

Do not use Pantoprazol Vir Pharma after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Pantoprazol Vir Pharma 40 mg in polyethylene bottle: no special storage conditions required.

Pantoprazol Vir Pharma 40 mg in aluminum/aluminum blister: do not store above 30°C.

Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

Composition ofPantoprazolVir Pharma

The active ingredient is pantoprazol. Each gastro-resistant tablet contains 40 mg of pantoprazol(in the form ofsodium sesquihydrate).

The other components (excipients) are:

Core: mannitol (E-421), microcrystalline cellulose, anhydrous disodium phosphate,croscarmellose sodium,magnesium stearate.

Covering:hydroxypropyl methylcellulose (hypromellose), sodium glycolate of potato starch,trietil citrate, copolymerof methacrylic acid-ethyl acrylate (1:1),yellow iron oxide (E-172).

Appearance of the product and contents of the package

Gastro-resistant tablet of yellow color, oval, concave, smooth.

Packages: bottles (polyethylene high-density container with a polypropylene lid provided with a desiccant) and blisters (Alu/Alu blisters). Each package contains 14 or 28 gastro-resistant tablets.

Holder of the marketing authorization and Responsible for manufacturing

Holder of the marketing authorization:

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industrial URTINSA II.

28923 (Alcorcón) Madrid

Spain

Responsible for manufacturing:

TEVA PHARMA S.L.U.

Polígono Malpica C/ C, 4

50016 Zaragoza

Spain

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/Laguna 66-70. Polígono Industrial URTINSA II.

28923 (Alcorcón) Madrid

Spain

This prospectus was approved in October 2020.

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/